Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050597
Company: DR REDDYS LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AUGMENTIN '125' AMOXICILLIN; CLAVULANATE POTASSIUM 125MG;EQ 31.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, CHEWABLE;ORAL Discontinued None Yes No
AUGMENTIN '250' AMOXICILLIN; CLAVULANATE POTASSIUM 250MG;EQ 62.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, CHEWABLE;ORAL Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/22/1985 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/22/2013 SUPPL-49 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050564s053s055,050575s040s042,050597s047s049,050720s026s028,050725s028s030,050726s022s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050564Orig1s053s055,050575s040s042,050597s04s049,050720s026s028,050720s026s028,050725s028s030,050726s022ltr.pdf
01/22/2013 SUPPL-47 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050564s053s055,050575s040s042,050597s047s049,050720s026s028,050725s028s030,050726s022s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050564Orig1s053s055,050575s040s042,050597s04s049,050720s026s028,050720s026s028,050725s028s030,050726s022ltr.pdf
09/29/2011 SUPPL-46 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050597s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050575s039,050597s046,050725s027,050726s021ltr.pdf
03/27/2008 SUPPL-45 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050597s45,050575s38,050726s20,050725s26lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050597s045, 050575s038, 050726s020, 050725s026ltr.pdf
12/04/2008 SUPPL-44 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050575s037550597s044050725s025050726s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050575s037, 050597s044, 050725025, 050726s019ltr.pdf
08/11/2004 SUPPL-43 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50575s036,50597s043,50725s024,50726s018ltr.pdf
06/03/2004 SUPPL-42 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50575slr035,50597slr042,50725slr023,50726slr017ltr.pdf
10/17/2002 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

12/04/2002 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

05/12/2003 SUPPL-39 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50575slr032,50597slr039,50725slr017,50726slr014ltr.pdf
03/28/2002 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

04/17/2001 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

03/29/2001 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

11/19/1999 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

09/23/1999 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

02/01/1999 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

04/10/2002 SUPPL-30 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50564s34ltr.pdf
02/19/1998 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

02/11/1998 SUPPL-28 Labeling

Label is not available on this site.

03/19/1997 SUPPL-27 Labeling

Label is not available on this site.

03/04/1996 SUPPL-24 Labeling

Label is not available on this site.

07/06/1994 SUPPL-23 Labeling

Label is not available on this site.

06/21/1994 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/15/1994 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

02/16/1996 SUPPL-20 Labeling

Label is not available on this site.

07/21/1992 SUPPL-19 Labeling

Label is not available on this site.

05/04/1992 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

11/22/1991 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

09/16/1992 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

12/05/1991 SUPPL-15 Labeling

Label is not available on this site.

05/22/1991 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

03/09/1989 SUPPL-13 Labeling

Label is not available on this site.

07/02/1989 SUPPL-12 Efficacy-New Dosing Regimen

Label is not available on this site.

10/25/1991 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

09/20/1988 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

05/05/1988 SUPPL-9 Labeling

Label is not available on this site.

10/04/1989 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

11/27/1987 SUPPL-7 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/23/1987 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/30/1987 SUPPL-5 Labeling

Label is not available on this site.

09/21/1986 SUPPL-4 Labeling

Label is not available on this site.

12/21/1985 SUPPL-3 Labeling

Label is not available on this site.

11/26/1985 SUPPL-2 Labeling

Label is not available on this site.

09/27/1985 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/22/2013 SUPPL-49 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050564s053s055,050575s040s042,050597s047s049,050720s026s028,050725s028s030,050726s022s024lbl.pdf
01/22/2013 SUPPL-47 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050564s053s055,050575s040s042,050597s047s049,050720s026s028,050725s028s030,050726s022s024lbl.pdf
09/29/2011 SUPPL-46 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050597s046lbl.pdf
12/04/2008 SUPPL-44 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050575s037550597s044050725s025050726s019lbl.pdf
03/27/2008 SUPPL-45 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050597s45,050575s38,050726s20,050725s26lbl.pdf

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